SAN FRANCISCO, Oct. 13, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges Outset Medical, Inc. (NASDAQ: OM) investors who suffered substantial losses to submit your losses now.
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Outset Medical, Inc. (NASDAQ: OM) Investigation
The investigation focuses on the propriety of Outset Medical’s disclosures concerning marketing authorizations and commercialization of its flagship dialysis device, the Tablo Hemodialysis System (“Tablo”).
On June 13, 2022, when Outset revealed that in late May it implemented a shipment hold on Tablo for home use pending the FDA’s review and clearance of its 510(k) application, its 510(k) submission did not include data obtained through real-world human testing consistent with the FDA-approved protocol. As a result, Outset suspended 2022 and long-term financial guidance.
In late July 2022, Outset disclosed the FDA cleared the 510(k) application of Tablo for patient use in the home.
But on July 7, 2023, Outset Medical disclosed that it received an FDA Warning Letter asserting that: (1) the company’s website promotes a modality outside of current indications for Tablo; and (2) another 510(k) application was required for marketing authorization regarding TabloCart with Prefiltration (an accessory to the Tablo system).
More recently, on Oct. 12, 2023, Outset Medical reported disappointing preliminary Q3 2023 revenues and slashed its FY 2023 revenue guidance. The company blamed the shortfall on “a larger-than-expected impact in the field from the recent FDA warning letter, which served to elongate our sales cycle in several ways.”
These events have driven the price of Outset Medical shares sharply lower and recently prompted at least one analyst to double downgrade the company’s shares.
“We’re focused on investors’ losses and investigating whether Outset may have misled investors about Tablo’s near-term prospects,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in Outset Medical and have significant losses, or have knowledge that may assist the firm’s investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblowers: Persons with non-public information regarding Outset Medical should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email OM@hbsslaw.com.
About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation law firm focusing on corporate accountability through class-action law. The firm is home to a robust securities litigation practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and fraud. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
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Contact:
Reed Kathrein, 844-916-0895
